The government has sent a warning letter to the parent of an Atlanta medical device maker, saying an inspection earlier this year revealed “non-conformities” in the way it handled concerns about production processes.
The issue involves a St. Jude Medical Inc. facility that makes CardioMEMS HF, an implantable monitoring system for people who have had heart failure symptoms. Minnesota-based St. Jude, which bought the Atlanta operation in 2014, disclosed the letter in a regulatory filing last week.
The U.S. Food and Drug Administration inspected the Atlanta facility in June and questioned compliance with Current Good Practice Manufacturing regulations, the filing said.
The filing said the company “is in the process of working diligently to completely remediate the FDA’s observations…” It said the concerns do not regard the performance of CardioMEMS and will not affect manufacturing and shipment of the devices.
